Skip to Content

The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.

KELANU XL 10MG PROLONGED RELEASE TABLETS

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Kelanu XL 10mg prolonged release tablets (UK)

PACKAGE LEAFLET: INFORMATION FOR THE USER
KELANU XL 10 mg prolonged release tablets
(Alfuzosin hydrochloride)
Read all of this leaflet carefully before using this medicine.
- Keep this leaflet, you may need to read it again.
- If you have any further questions, please ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them
even if their symptoms are the same as yours.
- If any of the side effects gets serious or if you notice any side effects not listed in this leaflet,
consult your doctor or pharmacist.
In this leaflet:
1. What Kelanu XL is and what it is used for
2. Before you take Kelanu XL prolonged release tablets
3. How to take Kelanu XL prolonged release tablets
4. Possible side effects
5. How to store Kelanu XL prolonged release tablets
6. Further information

1. WHAT KELANU XL IS AND WHAT IT IS USED FOR
Kelanu XL belongs to a group of medicines called alpha-1-blockers.
Kelanu XL is used to treat moderate to severe symptoms of Benign Prostate Hyperplasia.
This is a condition where the prostate gland enlarges (hyperplasia), but the growth in itself is
not cancerous (benign). It occurs most often in older men.
The prostate gland is situated under the bladder surrounding the urethra (the tube that takes
your urine to the outside of the body). With age, the prostate gland may grow and press the
urethra making it smaller. This may cause problems with urination such as frequent urination
and difficulty in passing urine.
Kelanu XL works by relaxing the prostate gland muscle. This reduces the narrowing of the
urethra and so makes it easier to pass urine.

2. BEFORE YOU TAKE KELANU XL PROLONGED RELEASE TABLETS
DO NOT take Kelanu XL
If you are allergic (hypersensitive) to alfuzosin or to any one of the other ingredients in
the tablets (see Section 6). Symptoms of an allergic reaction include: a rash, swelling of
your lips, throat, or tongue, difficulty in swallowing or breathing.
If you are allergic (hypersensitive) to alfuzosin-equivalent substances (such as terazosin,
doxazosin).
If you have, or have had in the past, low blood pressure when standing up from a sitting
or lying position (the medical term for this is orthostatic hypotension). It can make you
feel dizzy, light-headed or faint when you stand or sit up quickly.

Page 1 of 6

Kelanu XL 10mg prolonged release tablets (UK)

If you are already taking another alpha-1-blocker (such as terazosin, doxazosin). See the
section below on ‘Taking Kelanu XL with other medicines’. In case of doubt please ask
your pharmacist or doctor.
If you have liver problems.
Take special care with Kelanu XL:
If you are taking other medicines to treat high blood pressure then your doctor will check
your blood pressure regularly, especially at the beginning of treatment.
If you experience dizziness, weakness or sweating within a few hours after you have
taken Kelanu XLthen you should lie down with your legs and feet raised up in the air
until the symptoms have disappeared. Usually, these effects last for only a short time and
occur at the start of the treatment. Normally, there is no need to stop treatment (see
Section 4).
If you have experienced a marked drop in blood pressure in the past after taking another
medicine belonging to the group of alpha-blockers. In this case your doctor will start
treatment with Kelanu XL at low doses and will gradually increase the dose.
If you have a condition where your kidneys are hardly working at all (severe kidney
problems).
If you are suffering from acute heart failure (insufficient pumping power of the heart).
If you suffer from chest pain (angina) and are being treated with a nitrate (medicines that
widen the tubes that circulate the blood in your body and make it easier for blood to
flow), as this may increase the risk of a drop in blood pressure. You should discuss with
your doctor whether to continue, or stop, your treatment with Kelanu XL, especially
when the chest pain recurs or worsens.
If you have an eye surgery for cataract (cloudiness of the eye) planned, tell your eye
specialist that you are using Kelanu XLor have previously been treated with an alphablocker. This is because Kelanu XLmay cause complications during your operation
which can be managed if your eye specialist is aware of this information before carrying
out the operation.
If you suffer from a defect in heart rhythm or you are taking medicines which may cause
a defect in heart rhythm (the medical term for this defect is QTc prolongation). In this
case your doctor should evaluate you before and during the period of administration of
Kelanu XL r.
Taking Kelanu XL with other medicines
Inform your doctor or pharmacist if you are taking or have recently taken other medicines.
This also applies to medicines obtained without prescription.
Do not use Kelanu XL at the same time as other alpha-blockers such as doxazosin,
prazosin, terazosin or tamsulosin (see the section “Do not take Kelanu XL tablets”).
If you are taking a medicine for high blood pressure (antihypertensive) or medicines used
to treat chest pain (nitrates) at the same time, you may get dizzy, weak or start sweating
within a few hours of taking this medicine. If this happens, lie down until the symptoms
have completely gone. Tell your doctor as he or she may decide to change the dose of
your medicine. (See section: “Take special care with Kelanu XL r”).
If you are going to have an operation that needs a general anaesthetic, tell your doctor
that you are taking Kelanu XLbefore the operation. Your doctor may decide to stop
Kelanu XL 24 hours before the operation. This is because it can be dangerous as this
medicine can lower your blood pressure.
The effect and side effects of Kelanu XL can be increased by certain medicines used for

Page 2 of 6

Kelanu XL 10mg prolonged release tablets (UK)

fungal infections (such as ketoconazole, itraconazole), certain antibiotics (such as
clarithromycin, erythromycin) and medicine used to treat HIV (such as ritonavir).
Taking Kelanu XL with food and drink
Take Kelanu XL after a meal.
You may feel dizzy and weak while taking Kelanu XL. If this happens do not drink any
alcohol.
Pregnancy and breast-feeding
This section does not apply as Kelanu XL is only used by men.
Effect on the ability to drive and use machines
You may feel dizzy and weak while taking Kelanu XL. Do not drive or operate any tools or
machines until you know how your body responds to the treatment.

3. HOW TO TAKE KELANU XL PROLONGED RELEASE TABLETS
Always take Kelanu XL tablets exactly as your doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
Swallow your tablets whole with plenty a fluid (for instance a glass of water).
Do not break, crush or chew your tablets. This can affect the release of your medicine
into the body
The first dose of this medicine should be taken just before going to bed
Take this medicine just after eating food (immediately after the same meal each day i.e.
at the same time each day). Do not take it on an empty stomach.
Adults:
The usual dose is one Kelanu XL 10 mg tablet once a day.
Older patients (> 65 years):
The usual dose is one Kelanu XL10 mg tablet once a day. The dose does not need to be
adjusted for the elderly (over 65 years).
Patients with mild to moderate kidney problems
Your dose does not need to be adjusted for mild to moderate kidney problems.
What you must do if you have taken more Kelanu XL than you should have done
Contact your doctor or your local hospital Accident and Emergency Department straight
away.
Take this leaflet or some tablets with you so your doctor will know what you have taken. Tell
the doctor how many tablets you have taken. Lie down as much as possible to help stop the
side effects.
Do not try to drive to the hospital yourself.
What you must do if you have forgotten to take Kelanu XL
Do not take a double dose to make up for a forgotten tablet as this may cause a sudden drop
in blood pressure. Skip the missed dose and take the next tablet as directed.
If you stop taking Kelanu XL

Page 3 of 6

Kelanu XL 10mg prolonged release tablets (UK)

You should not interrupt or stop taking Kelanu XL without speaking to your doctor first.
Take your tablets as directed and for as long as directed. Do not stop taking them even if you
feel better, as otherwise the symptoms may return.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines Kelanu XL can cause side effects, although not everybody gets them.
These side effects are most likely to happen at the start of treatment.
The following convention has been used for determining frequency of side effects:
Very common (in more than 1 in 10 patients)
Common (in more than 1 in 100 but less than 1 in 10 patients)
Uncommon (in more than 1 in 1000 but in less than 1 in 100 patients)
Rare (in more than 1 in 10,000 but less than 1 in 1000 patients)
Very rare (in less than 1 in 10,000 patients including reports of isolated cases)
The following side-effects may occur:
Very serious side effects
Reported very rarely (affects less than 1 in 10,000 patients)
Rapid swelling of the eyelids, face, lips, mouth and tongue, difficulty in breathing or
swallowing, rashes, hives and itching. These are symptoms of a very serious allergic
reaction. (The medical term for these symptoms is angioedema).
Feeling of tightness, heaviness, discomfort, or crushing pain that is felt behind the
breastbone and may spread to the arms, neck and jaw. (These may be manifestations of
Angina). Normally, this only happens if you have had angina before.
If any of the above mentioned side effects occur, stop taking Kelanu XL and tell your
doctor immediately or go to the Emergency department at your nearest hospital.
Other side effects include:
Common (affects more than 1 in 100 and less than 1 in 10 patients)
Feeling dizzy, light headed, or faint when you stand or sit up quickly (postural
hypotension).
Headache
Feeling sick (nausea)
Stomach pain
Loose stools (diarrhoea)
Dryness of mouth
Weakness or tiredness
Uncommon (affects more than 1 in 1000 and less than 1 in 100 patients)
Fast heart beat (tachycardia) and awareness of heart beat (palpitations)
Chest pain
Drowsiness
Being sick (vomiting)
Rashes, hives and itching

Page 4 of 6

Kelanu XL 10mg prolonged release tablets (UK)

Flushes
Water retention (may cause swollen arms or legs)
General feeling of being unwell
Visual disturbances
Inability to retain urine (urinary incontinence)
Runny nose
Very rare side effects (affects less than 1 in 10,000 patients)
Yellowing of skin and whites of eyes with decreased appetite and stomach pain (these
may be manifestations of a liver problem)
Prolonged and painful erection of the penis, unrelated to sexual activity (these may be
manifestations of a medical condition called priapism)
Side effects where frequency is not known
During operations on the eye for cataracts (cloudiness of the lens) the pupil (the black
circle in the middle of your eye) may not increase in size as required. Also, the iris (the
coloured part of the eye) may become floppy during surgery.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
5.

HOW TO STORE KELANU XL PROLONGED RELEASE TABLETS
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Do not use Kelanu XL prolonged release tablets after the expiry date which is stated on
the carton after: EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask you
pharmacist how to dispose of medicine no longer required. These measures are to help
protect the environment.

6.

FURTHER INFORMATION
What Kelanu XL prolonged release tablets contain
The active substance is alfuzosin hydrochloride.
Each prolonged release tablet contains 10 mg of alfuzosin hydrochloride.
The other ingredients are:
hypromellose (E464), hydrogenated vegetable oil, povidone (E1201), calcium hydrogen
phosphate (E341), carbomer, silica colloidal anhydrous (E551), magnesium stearate (E470b),
propylene glycol (E1520), titanium dioxide (E 171).
The tablet has a prolonged effect which means that after taking the active substance is
not released immediately but gradually from the tablet and therefore acts longer.
What Kelanu XL prolonged release tablets look like and contents of the pack
Kelanu XL 10 mg prolonged release tablets are white to off-white, round, biconvex, film-

Page 5 of 6

Kelanu XL 10mg prolonged release tablets (UK)

coated tablets debossed with ‘X’ on one side and ‘47’ on the other side.
Kelanu XL10 mg prolonged release tablets are available in Alu / Alu blister packs, and
HDPE tablet container with a silica gel dessicant.
Pack size:
Alu / Alu blister pack: 10, 14, 20, 28, 30, 50, 56, 60, 84, 90 and 100 tablets
HDPE container pack: 30 and 1000 tablets

Not all pack sizes may be marketed.
Marketing authorization holder
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland
Manufacturer:
Pfizer Service Company,
Hoge Wei 10, B – 1930, Zaventem, Vlaams Brabant,
Belgium
and
Pfizer Italia s.r.l.,
Località Marino del Tronto, Ascoli Piceno,
Italy

This leaflet was last approved in
07/2013

Text in grey refers to HDPE bottle specific text which is not marketed in UK, but included in
final EU text, and not included in UK leaflet

Page 6 of 6

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide